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K Number
K012730
Device Name
CLEARFIL PORCELAIN BOND ACTIVATOR
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-13

(30 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K871636,K900690,K925404
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEAFIL PORCELAIN BOND ACTIVATOR is indicated for the following applications:

  1. Repair of porcelain or porcelain fused-to-metal crowns and bridges
  2. Restoration of gingival porcelain areas where bonding to porcelain is necessary
  3. Increased retention of porcelain inlays, onlays, crowns and veneers
  4. Increased retention of composite inlays and onlays
Device Description

This product is contained in CLEARFIL PORCELAIN BOND (K871636) and CLEARFIL VENEER BOND (K900690) which has been submitted to FDA as 510k notifications and permitted to be marketed already.

AI/ML Overview

The provided text (K012730) describes a 510(k) premarket notification for a medical device called "CLEARFIL PORCELAIN BOND ACTIVATOR." However, this document does not contain information about acceptance criteria, device performance metrics, or any studies using AI or human readers.

The 510(k) submission is specifically to:

  • Alter the name and address of the manufacturer from Kuraray Co., Ltd. to Kuraray Medical Inc.
  • Confirm that the device is substantially equivalent to a previously cleared predicate device (CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co., Ltd., K925404).

The document explicitly states that "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes" and "This device is essentially the same as CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Co., Ltd. (K925404). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL PORCELAIN BOND ACTIVATOR."

Because of this, there are no new studies or performance data presented in this specific 510(k) summary. All performance and safety data would have been part of the original K925404 submission for the predicate device.

Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not addressed in this document.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.